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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBARD LIFESTENT VASCULAR STENT SYSTEMS
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBARD PERIPHERAL VASCULAR, INC.
1415 WEST 3RD ST.
TEMPE, AZ 85281
PMA NumberP070014
Supplement NumberS022
Date Received03/10/2011
Decision Date09/16/2011
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A 200 MM LENGTH STENT AND A NEW DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BARD LIFESTENT SOLO VASCULAR STENT SYSTEM AND IS INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DENOVO OR RESTENOTIC LESIONS UP TO 240 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 - 6.5 MM.
Post-Approval StudyShow Report Schedule and Study Progress
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